EnterostomyCHYMERENCT06751628
Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery
An observational study of Enterostomy, run by Nantes University Hospital at 1 site in France.
Trial summary
High-output enterocutaneous fistulas (HOF) and double enterostomies are severe complications of abdominal surgery or trauma. Double enterostomies are typically created after small bowel resection in fragile patients who cannot tolerate intestinal reconnection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterostomy
- What is being tested?
- Insides system
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jul 2024to 14 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HOF (High-Output Fistulas) who are candidates for chyme reinfusion (CR) using the Insides System device will be included in the study during the pre-implantation consultation or a follow-up consultation. Patient characteristics prior to CR, as well as data related to the objectives mentioned above, will be collected both before device implantation and up to three months after intestinal reconnection
Who may be able to join
- High-output stoma or enterocutaneous fistula (>1500 mL per day or >1000 mL per day with impact on hydration and nutritional status) Double enterostomy or enterocutaneous fistula with an anatomical configuration allowing chyme reinfusion (CR) Confirmed patency of the downstream digestive segment through digestive contrast imaging
Who cannot join
- Stricture or fistula in the downstream digestive segment Patient refusal to use the device Fine motor or cognitive impairments preventing the patient or a caregiver from handling the device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, Nantes, 44000
EMILIE DUCHALAIS, MD; PhD, 0253484322, EMILIE.DUCHALAIS@CHU-NANTES.FR
About this study
High-output enterocutaneous fistulas (HOF) and double enterostomies are severe complications of abdominal surgery or trauma. Double enterostomies are typically created after small bowel resection in fragile patients who cannot tolerate intestinal reconnection. Reconnection is generally performed 3-6 months later, once patients have regained sufficient healing capacity. In contrast, HOFs occur when intestinal anastomosis healing fails, causing digestive secretions to exit through the abdominal wall. HOFs lead to excessive loss of fluids and nutrients, defined as digestive output exceeding 1500 mL per day for two consecutive days. This often results in severe dehydration and intestinal failure.
Managing HOFs is a complex, resource-intensive process requiring multidisciplinary care to compensate for losses and ensure patient survival. These conditions cause significant patient burden, increase healthcare costs, and often necessitate parenteral nutrition (PN). PN is associated with longer hospital stays, higher risks of central line infections, venous thrombosis, and liver complications (de Vries et al., 2021).
Read more
Innovative approaches are needed to restore lost digestive fluids and nutrients in HOF patients. Such solutions could mitigate intestinal failure, reduce PN reliance, prevent dehydration and kidney failure, shorten hospital stays, and improve quality of life by enabling home care. Chyme reinfusion (CR) is an established technique for transferring digestive fluids back into the bypassed intestine (Figure 1A). Historically, this procedure relied on bulky peristaltic pumps available only in specialized centers, with fewer than ten centers in France offering the service. CR has shown significant benefits, with over 85% of patients discontinuing PN and improving nutritional status (Bhat et al., 2020).
A novel, portable pump system developed by Insides System allows patients to independently perform CR and manage their care in outpatient settings. A case series of 10 patients demonstrated that the Insides System enabled PN discontinuation, corrected liver and electrolyte imbalances, and allowed most patients to return home with CR (Sharma et al., 2017).
The CHYMERE study aims to evaluate the effectiveness of chyme reinfusion using a home-compatible device for patients with HOF.
Read the detailed description
The nutritional data and the quantification of digestive losses will be compared between the period preceding chyme reinfusion (CR) and the CR period using appropriate tests based on the quantitative or qualitative nature of the data. Other endpoints recorded after the start of CR will be analyzed using a descriptive and analytical methodology.
- Conditions
- Enterostomy
- Being tested
- Insides system
- Keywords
- Reinstillation, Small bowel surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insides systemDevice
The miniaturization of the pump proposed by Insides System enables the patient to perform CR independently and to carry the pump anywhere, thus facilitating outpatient implementation of CR.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of the Insides System device
reducing the use of parenteral nutrition (median)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start14 Jul 2024
- Primary completion14 Jul 2029 (estimated)
- Study completion14 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnterostomyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751628
- Sponsor's protocol ID
- AP_ED_002
- Acronym
- CHYMERE
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery
- ClinicalTrials.gov ID
- NCT06751628
- Acronym / sponsor ID
- CHYMERE / AP_ED_002
- Conditions
- Enterostomy
- Keywords
- Reinstillation, Small bowel surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 14 Jul 2029 (estimated)
- Study completion
- 14 Jul 2030 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-output enterocutaneous fistulas (HOF) and double enterostomies are severe complications of abdominal surgery or trauma. Double enterostomies are typically created after small bowel resection in fragile patients who cannot tolerate intestinal reconnection. Reconnection is generally performed 3-6 months later, once patients have regained sufficient healing capacity. In contrast, HOFs occur when intestinal anastomosis healing fails, causing digestive secretions to exit through the abdominal wall. HOFs lead to excessive loss of fluids and nutrients, defined as digestive output exceeding 1500 mL per day for two consecutive days. This often results in severe dehydration and intestinal failure.
Managing HOFs is a complex, resource-intensive process requiring multidisciplinary care to compensate for losses and ensure patient survival. These conditions cause significant patient burden, increase healthcare costs, and often necessitate parenteral nutrition (PN). PN is associated with longer hospital stays, higher risks of central line infections, venous thrombosis, and liver complications (de Vries et al., 2021).
Innovative approaches are needed to restore lost digestive fluids and nutrients in HOF patients. Such solutions could mitigate intestinal failure, reduce PN reliance, prevent dehydration and kidney failure, shorten hospital stays, and improve quality of life by enabling home care. Chyme reinfusion (CR) is an established technique for transferring digestive fluids back into the bypassed intestine (Figure 1A). Historically, this procedure relied on bulky peristaltic pumps available only in specialized centers, with fewer than ten centers in France offering the service. CR has shown significant benefits, with over 85% of patients discontinuing PN and improving nutritional status (Bhat et al., 2020).
A novel, portable pump system developed by Insides System allows patients to independently perform CR and manage their care in outpatient settings. A case series of 10 patients demonstrated that the Insides System enabled PN discontinuation, corrected liver and electrolyte imbalances, and allowed most patients to return home with CR (Sharma et al., 2017).
The CHYMERE study aims to evaluate the effectiveness of chyme reinfusion using a home-compatible device for patients with HOF.
Detailed description
The nutritional data and the quantification of digestive losses will be compared between the period preceding chyme reinfusion (CR) and the CR period using appropriate tests based on the quantitative or qualitative nature of the data. Other endpoints recorded after the start of CR will be analyzed using a descriptive and analytical methodology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HOF (High-Output Fistulas) who are candidates for chyme reinfusion (CR) using the Insides System device will be included in the study during the pre-implantation consultation or a follow-up consultation. Patient characteristics prior to CR, as well as data related to the objectives mentioned above, will be collected both before device implantation and up to three months after intestinal reconnection
Key inclusion criteria (1 listed)
- High-output stoma or enterocutaneous fistula (>1500 mL per day or >1000 mL per day with impact on hydration and nutritional status) Double enterostomy or enterocutaneous fistula with an anatomical configuration allowing chyme reinfusion (CR) Confirmed patency of the downstream digestive segment through digestive contrast imaging
Key exclusion criteria (1 listed)
- Stricture or fistula in the downstream digestive segment Patient refusal to use the device Fine motor or cognitive impairments preventing the patient or a caregiver from handling the device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insides systemThe miniaturization of the pump proposed by Insides System enables the patient to perform CR independently and to carry the pump anywhere, thus facilitating outpatient implementation of CR. | Device | – |
Primary outcome
To determine the effectiveness of the Insides System device
Time frame: 1 year
reducing the use of parenteral nutrition (median)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Enterostomy
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
Enterostomy
RecruitingObservational study
Enteral Nutrition in Infants With Ileostomy
Nutrition of Ileostomy Infants
Not yet recruiting
Construction and Empirical Research of the Applicable Baduanjin Protocol for Patients With Colorectal Cancer Enterostomy
Colorectal Cancer
Recruiting
Postoperative Effects of Different Enterostomy Approaches
Colorectal Cancer, Colorectal Neoplasms Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterostomy, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMILIE DUCHALAIS, MD PhD (0253484322, EMILIE.DUCHALAIS@CHU-NANTES.FR), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effectiveness of the Insides System device (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.